UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013798 |
|---|---|
| Receipt number | R000016102 |
| Scientific Title | PET study of the density ratio of the serotonin 2A receptors and D2 receptors in the each subregions of the prefrontal cortex |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2016/08/09 19:19:04 |
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Basic information
Public title
PET study of the density ratio of the serotonin 2A receptors and D2 receptors in the each subregions of the prefrontal cortex
Acronym
PET study of the density ratio of the serotonin 2A receptors and D2 receptors in the each subregions of the prefrontal cortex
Scientific Title
PET study of the density ratio of the serotonin 2A receptors and D2 receptors in the each subregions of the prefrontal cortex
Scientific Title:Acronym
PET study of the density ratio of the serotonin 2A receptors and D2 receptors in the each subregions of the prefrontal cortex
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the density ratio of the serotonin 2A receptors and D2 receptors in the each subregions of the prefrontal cortex.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The binding potential ratio of the serotonin 2A receptor Binding potential and D2 receptor Binding potential in the each subregions of the prefrontal cortex
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
PET/MRI/neuropsychological batteries/neurological examinations
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
20y.o.<=40<y.o.healthy male volunteers participated in the study Serotonergic system and subjective perception
Healthy volunteers eligible for this study
Healthy volunteers with ability to make informed consent
Key exclusion criteria
History of psychiatric diseases, sever physical diseases, neurological diseases
Implanted metal or tatto in the body
Claustrophobia
Those who was considered to be inapptopriate to participate in the study
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Kimura |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
81432063025
y-kimura@nirs.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Ishii |
Organization
National Institute of Radiological Sciences
Division name
Molecular Imaging Center
Zip code
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
81432063025
Homepage URL
tishii@nirs.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
Funding Source
Organization
National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 23 | Day |
Last modified on
| 2016 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016102
